Urinary catheter assembly allowing for non-contaminated insertion of the catheter into a urinary canal

ABSTRACT

A catheter assembly allowing for non-contaminated insertion of the catheter into the urinary canal. The catheter assembly includes a urinary catheter, a catheter package and a sealing member. The urinary catheter defines a conduit and has a proximal end adapted for insertion into the urinary canal and an opposite distal end. The catheter package has a hose with a cavity for accommodation of the catheter, and a catheter outlet adapted to dismantle the proximal end of the catheter from the catheter package. The sealing member is adapted to provide a substantially liquid-tight seal between the catheter package and the urinary catheter while the catheter is being dismantled.

FIELD OF THE INVENTION

The present invention relates to a urinary catheter assembly comprisinga package allowing for storage of the catheter and for contaminationfree insertion of the catheter into a natural or an artificial urinarycanal of an individual.

BACKGROUND OF THE INVENTION

Catheters for draining the bladder are increasingly used forintermittent as well as indwelling or permanent catheterisation.Typically catheters are used by patients suffering from urinaryincontinence or by disabled individuals like para- or tetraplegics whomay have no control permitting voluntary urination and for whomcatheterisation may be the way of urinating e.g. permitting theindividual to stay seated in a wheel chair or lying in bed.

Typically, catheters are provided to the user enveloped in a completelysealed and sterilised package. During use and prior to insertion, thecatheter is typically removed completely from the package whereby apotential contamination of the catheter may occur, e.g. if the userunintentionally touches the catheter or if the catheter touchessurrounding obstacles, toilet seat, wash basin etc. Catheter packagesand assemblies of catheters and packages exist, wherein both a proximalend and a distal end of the package may be opened, thus allowing fordraining the urine through a catheter which is still at least partlyenveloped in the package. Thereby, the user may urinate withoutcompletely exposing the catheter and the risk of contamination isreduced. However, since there is a clearance between the inner surfaceof the catheter package and the outer surface of the catheter itself,urine may flow backwards in the package in a direction opposite to theflow direction inside the catheter. An unwanted situation is that theuser of the catheter and/or the surroundings gets contaminated by urineor other liquid substances, e.g. a lubricant or water applied to thecatheter for the purpose of reducing the surface friction.

Since only the inserted part of the catheter is exposed from one end ofthe package prior to insertion of the catheter, another unwantedsituation may be that the user unintended forgets to open the other endof the catheter package. An amount of urine may thereby build up in thecatheter package and possibly cause a back-flow in the catheter tube. Inthis case there is a risk of severe contamination of the surroundingsand also a possibility of back-flow into the bladder.

Moreover, existing catheters are provided in various sizes. As anexample, catheters, which are relatively long, are offered for maleindividuals whereas relatively short catheters are offered for femaleindividuals. The at least two variants, imply problems and costs for theproviders of urinary catheters.

Catheter assemblies comprising a catheter and a package which includesan amount of a liquid substance, e.g. a lubricant for a conventionalcatheter or a liquid swelling medium for a hydrophilic catheter, exist.Some of the existing packages provide a combination between a storagevolume for sterile storage of the catheter and a reservoir forcollection of liquid substances, e.g. for collection of frictionreducing substances or for collection of urine. Typically there is alarge disproportion of the storage capacity necessary for storing thefriction-reducing substance and the urine, respectively. Accordingly,the known catheter assemblies of this kind are provided with arelatively small storage container for storing the friction-reducingsubstance inside the relatively large urine reservoir. It is adisadvantage of the known assemblies that the user, prior to insertionof the catheter into the urinary canal, will have to rupture the storagecontainer in order to achieve a reduced surface friction of thecatheter. Especially, it is a disadvantage in the event that thecatheter is a hydrophilic-coated catheter. In this event, the user wouldneed to open the storage container to allow a liquid swelling mediumstored therein to activate the coating and then wait for at least 30seconds in order to complete the activation prior to insertion of thecatheter.

SUMMARY OF THE INVENTION

It is an object of the present invention to overcome the above-describeddisadvantages of the known catheter assemblies by providing a urinarycatheter assembly which, according to a first aspect of the invention,allows for non contaminated insertion of a catheter into a urinarycanal, said assembly comprising a urinary catheter defining a conduitand having a proximal end adapted for insertion into a urinary canal ofan individual and an opposite distal end, and a catheter package havinga generally tubular body such as a hose with a cavity for accommodationof the catheter. The proximal end of the package includes a catheteroutlet through which the proximal end of the catheter can be“dismantled” or projected from the catheter package upon openingthereof. The assembly further includes sealing means adapted to providea substantially liquid tight seal between the catheter package and theurinary catheter, while the catheter is being dismantled or projectedfrom the package.

The sealing means may be provided in the proximal end of the package,e.g. constituting a closure for the proximal end of the package. As anexample, the closure may have a rupturable portion with a shape whichmatches the outer cross-sectional shape of the catheter. When thecatheter is removed through the rupturable portion, the closure willsealingly surround the catheter while the catheter is being dismantled.The cavity is thereby defining a receptacle between the catheter and thehose. The receptacle may e.g. be used for storage of a friction-reducingsubstance.

The sealing means may also be arranged between an outer surface of theurinary catheter and an inner surface of the hose. As an example, thesealing means may be provided in the form of a sliding seal adapted tomove in relation to either one of the inner surface of the hose, theouter surface of the catheter or both, while still providing asubstantial liquid tight passage therein between. The cavity therebydefines an upper receptacle located near the proximal end of the packageand an oppositely located lower receptacle between the catheter and thehose. Especially the upper receptacle may advantageously be used forstoring a friction reducing substance for treatment of at least theproximal end of the catheter in the package.

The catheter or at least a part of the catheter could be made fromsilicone or from a thermoplastic elatomeric material, otherthermoplastic materials, curable elastomeric materials, polyamide resinsor elastomers or any mixture thereof, i.e. the group may comprisematerials like, PVC, PU, PE, latex, and/or Kraton™.

Preferably the catheter is provided with a bending moment defined as theproduct between E-modulus and moment of inertia of at least 1 MPamm⁴.

Since the proximal (insertable) end of the catheter, for maleindividuals, must pass prostate in a curved passage, the proximal endportion of the catheter, e.g. the first 10-50 mm. such as 20-40 mm.,such as 25-35 mm, such as the first 30 mm. of the catheter may beprovided with an even lower bending moment defined as the productbetween E-modulus and moment of inertia of less than e.g. 0.6 MPamm⁴ oreven less than 0.3 MPamm⁴. Other parts of the catheter, e.g. a distalend portion where the urine is drained into the toilet, a bag or placeof disposal, may similarly be provided with a different bending moment.

The cross-sectional flow area or the hydraulic radius defined as theratio of the cross-sectional flow area to the wetted perimeter, may beselected independently upon the length, e.g. on the basis of the size ofthe urinary canal, which size preferably differs between theindividuals.

Preferably, the catheter is provided in an insertable length in therange of 50-90 mm., such as in the range of 55-85 mm., such as in therange of 60-80 mm. such as with a length in the size of 70 mm. whichlength has been found to be a suitable insertable length for most femaleindividuals. For male individuals, the insertable length of the cathetermay preferably be provided in the range of 180-250 mm., such as in therange of 190-240 mm., such as in the range of 200-230 mm. such as in thesize of 220 mm. For the male individuals it may further be preferred toprovide at least a part of the inserted end of the catheter in amaterial or in dimensions so that a the tube becomes very flexible inorder to easy the passage of the catheter past prostate.

The inner cross-sectional shape of the catheter should preferably besubstantially circular with a cross-sectional area in the range of 0.5mm²-50 mm².

The outer cross-sectional shape and size of the catheter should beprovided with regards to the size of the urinary canal and/or thepassage into the bladder so that the catheter around the outer surfacethereof seals liquid-tightly.

The catheter or at least a section thereof may be provided with ahydrophilic surface. When treated with a liquid swelling medium, such asurface will provide an excellent lubrication for the insertion and alsoprovide compatibility with the body tissue.

However, the catheter may also be of the traditional type wherein thelow friction character is obtained by application of a lubricantdifferent from water, e.g. a silicone based lubricant, the lubricantbeing applied to at least a section of the catheter.

The liquid swelling medium for a hydrophilic surface may be provided inthe package, especially in the upper storage compartment, near theproximal end of the catheter, when the catheter is arranged in thepackage. Thereby, the low friction character will be initiated alreadywhen the catheter is being arranged in the package. The liquid swellingmedium may simply be a saline solution, a bactericidal solution capableof swelling the hydrophilic surface and capable of keeping the surfacein a sterile condition or it may be any suitable liquid swelling medium.The swelling may also be initiated already before packaging of thecatheter, the catheter then being packed in a substantially gasimpermeable package for conservation of the moistened surface.Furthermore, the liquid swelling medium may be provided in a capsule orcontainer directly within the hose member together with the catheter forswelling of the hydrophilic material immediately prior to the insertion.

It is an advantage to provide the catheter package in a material whichis at least substantially gas and water impermeable, which is durable toat least moderate external conditions, such as temperature variationsand light. The material should at least substantially maintain itsproperties over a period of up to 12 or more months, e.g. up to 24month. The catheter package and/or the hose member could thereforepreferably be made from silicone or a thermoplastic elatomeric material,other thermoplastic materials, curable elastomeric materials, polyamideresins or elastomers or any mixture thereof, i.e. the group may comprisematerials like, PA, PP, PVC, PU, PE, latex, and/or Kraton™. All parts ofthe catheter package may be made from two foils of a sheet materialjoined along edges, e.g. by melting or gluing the foils together or thepackage may be made from an extruded substantially tubular member beingclosed in both ends. The foil may advantageously be made from laminatesof different materials. One layer may e.g. be a layer of aluminium orsimilar metal for provision of a completely gas-impermeable package.

The proximal end and the distal end of the catheter package could beprovided with an even structure. However, it will be preferred that theproximal end of the package is provided with opening means adapted toremove the proximal end of the catheter. Similarly, the distal end ofthe package may be provided with opening means adapted specifically fordraining fluid substances from the package. The fluid substances mayeither be a friction-reducing medium or urine.

Preferably, the hose member is an elongate and/or tubular member adaptedto accommodate at least a major part of the catheter. If the catheter isof the kind which develops a low friction surface character upontreatment with a liquid medium or substance, it may be an advantage toprovide the liquid medium in the package and preferably in the hosemember. The catheter will thereby be treated already upon removal of thecatheter from the package. For this purpose, the hose member maypreferably be adapted to relatively closely enclose the catheter. As anexample, the inner diameter of the hose member may preferably be in therange of 1.1-2 times the outer diameter of the catheter, such as 1.2-1.9times, such as 1.3-1.8, such as 1.4-1.7, such as 1.5-1.6, such as in thesize of 1.55 times the outer diameter of the catheter. Alternatively,the liquid medium may be contained in a pouch connected to the package.The pouch may e.g. constitute a closure for closing either the proximalor the distal end of the package. Preferably, the pouch is integrated ina closure for closing the proximal end of the package, which end islocated near the proximal end of the catheter.

If the catheter is a hydrophilic catheter, i.e. if the catheter iseither coated with a hydrophilic coating or made completely from ahydrophilic material, the liquid substance may be water or awater/saline solution. If the catheter is of the traditional type havinga primarily hydrophobic surface, the liquid substance may be alubricant, e.g. based on silicone.

The sealing means could be provided in the form of an obstruction whichsubstantially prevents a liquid substance to pass between the innersurface of the package and outer surface of the catheter. The sealingmeans thus divides the space confined between the catheter and the hosemember into an upper receptacle, in the direction towards the proximalend of the catheter and package and a lower receptacle, in the directiontowards the distal end of the catheter and package.

As an example, the sealing means could be provided as a radiallyoutwardly extending protrusion of the outer surface of the catheter oras an inwardly extending protrusion of the inner surface of the hosemember, e.g. in the form of a resilient vane adapted to contact theinner surface of the hose member or outer surface of the catheter,respectively. The outwardly extending protrusion of the catheter shouldin this respect be understood either as a protrusion connected to thecatheter or a protrusion formed directly on the surface of the catheter.As an example, the catheter may be connected with a plug member, whichplug member is provided with vanes adapted to slide along the innersurface of the hose or at least parts thereof. Similarly, the inwardlyextending protrusion of the hose should be understood either as aprotrusion connected to the hose or a protrusion formed directly on theinner surface thereof.

Two or more radially outwardly or inwardly extending protrusions of theouter or inner surfaces of the catheter and/or the hose member, willprovide an even better sealing against flow of liquid substances betweenthe two compartments. By providing the at least two radially inwardlyextending protrusions of the inner surface of the hose member withdifferent radial sizes, a further sealing effect will be achieved.

According to a preferred embodiment, the sealing means comprises a ringshaped member arranged between the inner surface of the hose member andthe outer surface of the catheter. As an example, a regular ring-shapedgasket may be placed inside the hose member. Preferably, the member isloosely arranged so that it is allowed to move back and forth inside thehose. As an example, the ring shaped member may be provided with aclearance against the hose member and against the catheter so thatliquid substances are substantially prevented from passing the ringshaped member and so that the ring shaped member is still allowed to beshifted longitudinally back and forth in the catheter package.

The ring shaped member may preferably be adapted to co-operate with aninwardly extending protrusion of the inner surface of the hose member orwith an outwardly extending protrusion of the catheter.

The distance from the distal end of the urinary catheter to the positionof the sealing means may preferably be provided between 0 and 100% ofthe total distance between the distal end of the catheter and theproximal end of the catheter, such as 0%, such as 10%, such as 20%, suchas 30%, such as 40%, such as 50%, such as 60%, such as 70%, such as 80%,such as 90%, such as 99%.

In general, the problems of introducing a catheter into the urethradepend not only of the size of the introduced part of the catheter butalso on the slipperiness of the introduced part. As previouslymentioned, the catheter or at least a part of the catheter adapted forinsertion into the urethra or an artificial urinary canal may often beprovided with a surface slipperiness for easy and safe insertion.However, it has been found that the slippery surfaces are difficult tohandle, not least for a user having reduced dexterity. It is thereforean important aspect of the present invention to allow the user tomanipulate the catheter by touching only the catheter package and onlyto “dismantle” or expose a length of the catheter which is necessary foropening the bladder. Preferably, the sealing means is arranged so as toseal between the outer surface of the catheter and the inner surface ofthe hose over a certain dismantling or projecting length. This willallow the user of the catheter to withdraw the catheter at least partlyfrom the package, e.g. by pulling the proximal end of the catheter outof the catheter package, meanwhile the sealing between the catheter andthe package remains. The feature allows that a catheter type of onelength can be supplied both to male and female users. The user onlyneeds to withdraw a length of the catheter from the catheter packagenecessary for opening the bladder, i.e. approximately 50-90 mm. forfemale users and approximately 180-250 mm. for male users.

The sealing means and/or the hose member may preferably be provided sothat a passage between the outer surface of the catheter and the innersurface of the hose member remains sealed while the catheter is beingdismantled or projected from the package over a first dismantle period,thus preventing fluid from passing between the urinary catheter and thehose member when the sealing means is positioned within said firstperiod.

In order not to contaminate the surroundings with friction-reducingsubstances, it is an advantage to allow such a substances which maypossibly be stored in the upper receptacle to drain down into the lowerreceptacle before dismantling or projecting the catheter through theproximal end of the package. The sealing means and/or the hose maytherefore preferably be provided so that a clearance is defined betweenthe outer surface of the urinary catheter and the inner surface of thehose member over a second dismantling period, thus allowing a fluid topass between the urinary catheter and the hose member when the sealingmeans is positioned within said second period. As the catheter is beingremoved from the package, the catheter enters the second dismantlingperiod. Any liquid substance contained in the upper receptacle isthereby drained down into the lower receptacle and it is thereby avoidedthat the substance might otherwise be unfortunately released though theproximal end of the package.

The length of the first dismantling period may preferably constitutebetween 0 and 100% of a total length of the package, such as 0%, such as10%, such as 20%, such as 30%, such as 40%, such as 50%, such as 60%,such as 70%, such as 80%, such as 90% or such as 100%.

According to one embodiment, the substantially liquid tight seal isprovided continuously between the catheter package and the catheter overthe first dismantle period. However, the liquid tight seal may also beprovided discontinuously.

Most catheters are provided with a surface which, when treated with afriction-reducing substance, exhibits a low friction surface character.Accordingly, it is an advantage that the package defines a liquid tightwetting pocket for treatment of the surface part with such substances.In the case that the catheter is hydrophilic or at least is providedwith a hydrophilic surface coating on at least the proximal end thereof,the substance would typically be a water based solution, e.g. a salinesolution. If the catheter is not hydrophilic, the substance may e.g. bea silicone based solution.

It is a further advantage to provide the assembly with an amount of thesubstance which is sufficient for effecting a treatment of at least apart of the catheter surface. As an example, the treatment may beperformed on a first part of the catheter, which part is adapted forinsertion into the urethra. The treatment may advantageously take placein the upper receptacle.

According to a preferred embodiment of the invention, the substance iscontained in a pouch connected to the assembly. The pouch may as anexample constitute a closure for closing one of either the proximal ordistal ends of the package, which end is preferably the proximal end ofthe package which end is located near the proximal end of the catheter.According to another preferred embodiment, the substance is applied tothe receptacle or at least the upper receptacle during the assemblingprocess. The low friction surface character of the catheter is therebyinitiated already from the time when the catheter assembly is produced.The package is therefore preferably formed with a wall of asubstantially gas impermeable material so as to allow long timepreservation of the catheter and a liquid substance in the package.

It is an advantage to provide the package with an opening for draining aliquid substance out of the package. As an example, the opening may beused for draining out surplus liquid swelling medium remaining in thepackage after treating a hydrophilic catheter. As another example, theopening may be used for draining urine out of the package. For thispurpose, the opening is preferably provided in the distal end of thepackage. During use, the individual may simply have to withdraw a lengthof the catheter which is sufficient for causing the urine to flow fromthe bladder. The urine will flow through the catheter conduit and intothe package. The urine is allowed to drain out of the package, e.g. intothe toilet or into a collection bag or reservoir connected to thepackage, through the opening. Preferably the opening is closed byclosing means connected to the catheter for causing opening of thepackage upon removal of the catheter from the package. As an example,the opening may closed by the distal end of the catheter itself.

According to a preferred embodiment of the invention, the closing meansconnected to the urinary catheter is provided with a flow channelco-operating with an outlet provided in the package. In a first positionof the closing means in relation to the outlet, liquid substances areallowed to flow from the conduit of the catheter and out of the package.In another position, liquid substance are prevented to flow from theconduit of the catheter and out of the package. The two positionscorresponding to a catheter respectively taken out of the package orbeing taken out of the package and a catheter arranged in the package.

The flow channel of the closing means may further comprise at least oneinlet allowing a liquid substance to flow between the one of either thelower or upper storage compartments and the conduit of the catheter. Inorder to prevent urine, drained through the catheter, from running outthrough the inlet, the inlet may be provided with means adapted to allowa liquid substance only to flow in the direction from one of either thelower or upper storage compartments and into the conduit.

Preferably, the hose is formed with a wall of a flexible material so asto allow the hose wall to be squeezed into contact with the catheter byfinger pressure. This will allow a user of the assembly to use the hoseas an applicator for guided non-contaminating insertion of the catheterinto the urinary canal. For that purpose, it is an advantage to providethe hose so that the user may vary the length of the hose. This willallow the user to contract the hose for exposing the proximal end of thecatheter through the catheter outlet.

The variable length may be provided by a telescopic arrangement of afirst part of the hose in relation to a second part of the hose or itmay be provided via a concertina folded wall part of the hose.

The package may preferably be closed in the proximal end by a detachableclosure, e.g. by a thin foil glued onto an opening of the proximal endof the package. This will allow the user to open the proximal end of thepackage by pushing the proximal end of the catheter though the foil,thereby letting the foil be penetrated by the catheter tip.

According to a preferred embodiment, the catheter assembly is providedwith a compartment being closed in a first end whereas in a secondopposite end it is detachably connected with the hose member. Thecompartment may preferably be formed with a wall of a flexible materialallowing the compartment wall to be squeezed into contact with thecatheter by finger pressure. Thereby, the compartment may be used as anapplicator for guided non-contaminating insertion of the catheter intothe urethra after opening the first closed end and detachment of thecompartment from the hose member. The compartment may preferably betubular and preferably, the hose member and compartment in combinationforms a tubular member of a length which allows for accommodation of atleast a mayor part of the catheter. Preferably, the catheter is arrangedinside the package so that it extends from the hose member and into thecompartment. Thereby, the user may grip the proximal end of the catheterby squeezing the compartment into contact with this part of the catheterand, upon detachment of the compartment from the hose member, insert thecatheter into the urethra.

A detachable cover member may preferably close the other end of thecompartment. After removal of the cover member, the user may draw theproximal catheter end out of the compartment, e.g. by squeezing thecompartment into contact with the catheter, withdrawing a piece of thecatheter from the hose member, releasing the squeezing grip of thecompartment and by moving the compartment down to a part of the catheternow layed open from the hose member. For this purpose, it is anadvantage to provide at least a first part of the hose member with awall of a flexible material so as to allow the first part of the hosewall to be squeezed into contact with the catheter by finger pressure.Thereby, the user can hold the catheter through the compartment wallwhile the catheter is moved out of the hose member and then hold thecatheter through the hose member wall, while the compartment is moveddown to a part of the catheter now being exposed. At this point, thecompartment may be used for holding the catheter while the catheter isinserted into the urethra. Only a certain length needed for the openingof the bladder is withdrawn from the hose member while the other part ofthe catheter remains inside the hose member. So as to avoidcontamination of the surroundings, the detachable cover member maypreferably be provided so that it can be re-connected to the compartmentafter catheterisation, thus leaving at least the proximal end of thepackage closed.

In order to facilitate coordinated operation of the hose member and thecompartment for non-contaminated insertion of the catheter into theurethra, at least a first part of the hose member and preferably thepart enveloping the proximal end of the catheter, may be formed with aconcertina folded wall. This will allow the length of the hose wall tobe extended and shortened respectively which again will facilitate easyremoval of the proximal end of the catheter from the hose member. As anexample, the proximal end of the catheter may be enveloped in the hosemember. In order to be able to squeeze the compartment into contact withthe catheter, the user will first have to move the catheter out of thehose member and into the compartment. With the concertina folded wall ofthe hose member, the user may simply press the compartment against theconcertina folded hose member. The length of the hose member is therebybeing reduced and the proximal end of the catheter is moved into thecompartment. The user may now grip the catheter through the compartmentwall and thus pull the proximal end of the catheter out of the catheterpackage without touching and possibly contaminating the catheter.

In order to provide a catheter assembly which is uncomplicated to useeven for persons with a reduced dexterity, the compartment, the covermember and/or at least a part of the hose member may be provided with agripping zone for easing the grip during use of the compartment forinsertion of the catheter into the urethra.

The gripping means may be provided as a radially extending flange orflanges of the compartment, cover member and/or the hose member or as azone or zones of the compartment, cover member and/or the hose memberhaving a large outer cross sectional diameter. The compartment, covermember and/or the hose member may also be provided with means forengaging an external handle. As an example, the compartment, the covermember and/or the hose member may be provided with a ring-shaped bulgefor attaching a handle.

The connection between the compartment and the hose member maypreferably be provided by a weakening line for tearing off thecompartment from the hose member.

The connection between the second compartment and the hose member may beprovided so that the connection can be re-established by twisting and/orpushing the second compartment onto the hose member.

The second compartment may be provided with a weakening line for openingthe first end by tearing off a first end part of the compartment.

For disabled users there may be severe difficulties in enteringavailable toilet rooms. It is therefore an advantage to make the use ofthe catheter totally independent of the availability of toilet rooms byconnecting a distal end of the package with a reservoir foraccommodation of a liquid substance. In this case, the catheter packageor at least the hose member thereof, may even be integrated in thereservoir.

It is an advantage to provide the reservoir in a material which isdurable to at least moderate filling with a liquid without causingdestruction of the reservoir or evaporation of the liquid substancethrough the walls of the reservoir. Moreover, the walls of the reservoirshould at least substantially maintain its properties over a period ofup to 12 or more month, e.g. up to 24 month. The reservoir couldtherefore preferably be made from a thermoplastic elatomeric material,other thermoplastic materials, curable elastomeric materials, polyamideresins or elastomers or any mixture thereof, i.e. the group may comprisematerials like, PA, PP, PVC, PU, PE, latex, and/or Kraton™. Preferably,the reservoir is made from two foils of a sheet material joined alongedges, e.g. by melting or gluing the foils together. The foils may e.g.be laminated from various materials and may e.g. comprise one layer ofaluminium or a similarly metallic layer for providing a completely gasimpermeable package.

It is an advantage if the reservoir is provided with a volume so that itwill never be filled to its limit. Accordingly, the reservoir maypreferably be provided with a volume in the range of 500-5000 ml, suchas 600 ml, such as 700, such as 800, such as 900 ml, such as 1000, suchas 1500 ml, such as 2000, such as 2500, such as 3000 ml, such as 3500,such as 4000 ml, such as 4500, such as 5000.

It is an advantage if the liquid substances, e.g. urine, is preventedfrom leaking out of the reservoir. Therefore, the connection between thedistal end of the package and the reservoir may be adapted to allow theliquid substance to flow only in a direction from the package to thereservoir. As an example, the connection may be provided with a one wayvalve or closure of the kind known in the art.

After catheterisation, many users would prefer to empty the reservoirbefore the catheter assembly or reservoir is disposed. It is thereforean advantage to provide a draining spout or valve for emptying thereservoir. The valve should at least be operable between a closed and anopen position. As an example, the valve could be a formed as a spoutwith a passage which is closed. The passage may as an example be closedby melting the reservoir together along a tear-off line. Aftercompletion of the catheterisation, the user simply tears off the tip ofthe spout and empties the reservoir.

In some cases, the user may have to carry a used catheter assembly withan emptied reservoir until an appropriate place of disposal isavailable. It is therefore an advantage to provide a draining spout witha closure enabling the user, after emptying the reservoir, to close ittightly. As an alternative to a detachable closure, a valve having anopen and closed position may be connected to the spout. As an example,the valve may be a regular valve 2-way-valve with an open and closedposition.

According to a second aspect, the present invention relates to acatheter assembly comprising a urinary catheter defining a conduit andhaving a proximal end adapted for insertion into the urinary canal of anindividual and an opposite distal end, and a catheter package having agenerally tubular body such as a hose with a cavity for accommodation ofthe catheter. A proximal end of the catheter package includes a catheteroutlet adapted to dismantle or project the proximal end of the catheterfrom the catheter package. In an opposite distal end of the package isan opening being closed by closing means connected to said catheter forcausing opening of the package upon removal of the catheter from thepackage. This aspect may be combined with any combination of embodimentsand aspects described for the first aspect of the present invention.

According to a third aspect, the present invention relates to a catheterassembly comprising a urinary catheter defining a conduit and having aproximal end adapted for insertion into the urinary canal of anindividual and an opposite distal end, and a catheter package having ahose with a cavity for accommodation of the catheter and, in a proximalend thereof, a catheter outlet adapted to dismantle or project theproximal end the catheter from the catheter package. The hose isprovided with a variable length, allowing the hose to be contracted forexposing the proximal end of the catheter through the catheter outlet,and any combination of embodiments and aspects described for the firstaspect of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention will now be described in detailswith reference to the drawing in which:

FIG. 1A shows cross-sectional view of a catheter assembly according to apreferred embodiment of the present invention,

FIG. 1B is a perspective view of one embodiment of a plug coupled to acatheter,

FIG. 1C is a cross-sectional view of one embodiment of the catheterassembly illustrated in FIG. 1A,

FIG. 1D is a cross-sectional view of the catheter assembly illustratedin FIG. 1C,

FIG. 2A is a perspective view of an alternative embodiment of a plugcoupled to a catheter,

FIG. 2B is a perspective view of the plug illustrated in FIG. 2A,

FIG. 2C is a cross-sectional view of one embodiment of a catheterassembly,

FIG. 2D is a cross-sectional view of one embodiment of a catheterassembly,

FIG. 3A is a perspective view of a catheter assembly,

FIG. 3B is a perspective view of a catheter assembly,

FIG. 3C is a perspective view of a catheter assembly,

FIG. 3D is a perspective view of plug for a catheter assembly,

FIG. 3E is a perspective view of plug for a catheter assembly,

FIG. 4A is an embodiment of a plug of a catheter assembly, where apassage between the catheter and a hose is sealed over a firstdismantling period and open over a second dismantling period,

FIG. 4B is a perspective view of plug for a catheter assembly,

FIG. 4C is a perspective view of a catheter assembly,

FIG. 4D is a perspective view of a catheter assembly,

FIG. 4E is a perspective view of a catheter assembly,

FIG. 5A though FIG. 5G illustrates seven sequences of the removal of acatheter from a catheter assembly,

FIG. 6A through FIG. 6C illustrates three different embodiments of theinvention wherein the a compartment for non-contaminated insertion ofthe catheter into a urinary canal is attached to the hose member,

FIG. 7A shows a perspective view of one embodiment of the invention,wherein the distal end of the package is closed by the distal end of thecatheter itself,

FIG. 7B is a perspective view of the package illustrated in FIG. 7A,

FIG. 7C is a perspective view of the package illustrated in FIG. 7A,

FIG. 8A shows an embodiment of the assembly shown in FIG. 7A, whereinthe distal end of the package is closed by a detachable closure,

FIG. 8B shows an embodiment of the assembly shown in FIG. 8A, whereinthe distal end of the package is open,

FIG. 8C is a perspective view of one embodiment of a detachable closure,

FIG. 9 is a perspective view of one embodiment of a catheter assemblyand a reservoir for storage of urine and other liquid substances,

FIG. 10 is a perspective view of one embodiment of a catheter assemblyand a reservoir for storage of urine and other liquid substances,

FIG. 11 is a perspective view of one embodiment of a catheter assemblyand a reservoir for storage of urine and other liquid substances.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Further scope of applicability of the present invention will becomeapparent from the detailed description given hereinafter. However, itshould be understood that the detailed description and specificexamples, while indicating preferred embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

Referring to FIG. 1A, FIG. 1B, FIG. 1C, and FIG. 1 d a catheter assemblyaccording to the present invention comprises a urinary catheter 1defining a conduit 2 for transportation of urine and other liquidsubstances, a catheter package 3 and sealing means 4. In this respectthe catheter is defined by a hose and by additional parts connected tothe hose, e.g. the plug 25. The plug combines the sealing between thecatheter and the package and the closing means adapted to close thedistal end of the package—see the following description. The catheter isprovided with a proximal end 5, adapted for insertion into the urethraof an individual. The catheter is provided with holes 6 arrangedperipherally around the proximal end part of the catheter for drainingurine from the bladder and into the conduit of the catheter. Thecatheter is further provided with at least one opening 7 in the oppositedistal end for draining liquid substances out of the conduit. Thepackage is provided with a hose 9 defining a cavity 10 for accommodationof the catheter.

The sealing means 4 is arranged between the outer surface 11 of thecatheter and the inner surface 12 of the hose member and provides asubstantially liquid tight division of the space confined between thehose member and the catheter into a lower receptacle 13 and an upperreceptacle 14.

As shown in FIG. 1C, the sealing means may preferably be provided in theform of a radially outwardly extending protrusion 4, e.g. in the form ofa soft, resilient vane of the catheter or attached to the catheter andprovided in a length which enables the vane to contact the inner surfaceof the hose member.

FIG. 1A shows a preferred embodiment of the assembly, wherein a flowchannel 15 is provided in order to allow a liquid substance to flow fromthe upper receptacle 14 and into the conduit 2, e.g. water or awater/saline solution contained in the upper receptacle for treatment ofa hydrophilic catheter or a lubricant for causing a low friction surfacecharacter of a conventional catheter.

FIG. 1B shows one embodiment of the sealing means connected to thecatheter.

FIG. 1C shows a situation wherein an opening 16 provided in the distalend of the package, allows liquid substances comprised in the lowerreceptacle to drain out of the package.

FIG. 1D shows a situation wherein closing means 17 of the catheterliquid tightly seals the opening 16. Preferably, the closing means isprovided with a number of resilient and/or soft bulges 18 adapted tocontact the inner surface of the opening 16.

FIGS. 1C and 1D further show a detachable closure 19 of the catheteroutlet 22 at the proximal end of the package. The closure may, asindicated in FIGS. 1C and 1D, preferably be attached to the package viaa strip 20, so that the assembly remains as one unit. The closure may beprovided with a radially extending gripping handle 21, easing theremoval of the closure, not least for individuals with a reduceddexterity.

FIGS. 2A, 2B, 2C and 2D shows an alternative embodiment of the plug 25and an alternative embodiment of the distal package end, wherein an opendistal end of the package is closed by a closure 26. The closure mayeither be detachable or glued onto the hose member 9. The plug ispreferably provided with at least one outlet opening 27 allowing urineflowing from the bladder and into the proximal end of the catheter todrain out of the catheter through the plug. The plug may further beprovided with an inlet 28 for draining a liquid substance from the upperreceptacle 14 and into the conduit 2. The closure 26 is further providedwith an opening 29 for draining liquid substances out of the lowerreceptacle, e.g. urine.

FIG. 2C shows a situation wherein the closing means of the catheter iswithdrawn from the closure, whereby the passage 29 is opened.

FIG. 2D shows a situation wherein the closing means of the catheter,closes the passage 29 and thereby prevents a liquid substance to drainout of the package.

The catheter and package shown in FIG. 2C and FIG. 2D are not drawn inits full length. The proximal ends of both have been omitted in order tofocus only on the differences between the embodiment of FIG. 1C and FIG.2C.

FIG. 3A shows an embodiment of the invention wherein the plug 35 isprovided with features similar to the plug 25 of FIG. 2A. The plugfurther comprises a groove 36 adapted to engage a ring shaped sealingmember 37. The ring shaped sealing member is provided inside the package38, either fixed to the inner surface of the hose or movably arranged sothat it is allowed to slide back and fourth in the hose.

FIG. 3C shows a situation wherein the ring shaped member engages thegroove

Like FIG. 2C, the proximal ends of both the catheter and the packagehave been left out, in order to focus only on the differences betweenthe embodiment of FIG. 2C and FIG. 3C.

FIG. 4A shows an embodiment of the invention where the plug 45 comprisesis provided with resilient vanes 46 provided with a diameter so thatthey over a first section 47 of the hose may contact the inner surface,when the plug is positioned within this section of the hose. However,the hose is provided with two different radial sizes. Accordingly, sincethe radial size of a second section 48 of the hose is larger than theradial size of the first section of the hose, the vanes 46 cannotcontact the inner surface of the hose, when the plug is positionedwithin the second section.

FIG. 5A shows an embodiment of the invention wherein the hose 9 isprovided with a variable length. The variable length is provided via aconcertina folded wall part 50 of the hose. The hose further forms twogripping zones 51,52 allowing the user to firmly grip the hose andshorten the length thereof, see e.g. FIG. 5 b. As shown in the FIGS. 5A,5B, 5C, 5D, 5E, 5F and 5G, the variable length allows the user to pushthe proximal catheter end out of the package by shortening the hoselength, gripping the catheter through the hose wall, extending the hoselength while the catheter is being gripped, releasing the grip and againshortening the length and vice versa. Accordingly, the hose wall 53 maypreferably be made from a flexible material allowing the wall to besqueezed into contact with the catheter by finger pressure.

FIG. 6A shows an embodiment of the invention, wherein a compartment 60is closed in a first end 61, whereas in a second opposite end 62 it isdetachably connected with the hose member 63. The compartment isprovided with two gripping zones 64,65 enabling the user to firmly gripthe compartment. Moreover, the compartment is provided with a concertinafolded wall section 66 enabling the user to reduce the length of thecompartment, in order to push the proximal end of the catheter 67 out ofthe proximal end of the package. The closure 69 for closing the firstend, is provided so that the package may be closed after thecatheterisation. This will allow the user to store the used catheterassembly without any risk of contamination of the surroundings. However,as previously described, the first end 61 may also be closed by atear-off compartment end, e.g. in the form of a thin foil glued to theend of the compartment.

The compartment may be detachably connected to the hose over a tear-offline, see FIG. 6A or alternatively, the compartment may be connected tothe hose member telescopically, by inserting one of either the hose orthe compartment into the other one of the hose or the compartment, seeFIGS. 6B, 6C.

FIG. 7A shows a simple embodiment of the invention wherein the package,in its distal end is provided with an opening 75. The opening may beclosed by the distal end 76 of the catheter itself, whereby the distalend of the package is automatically opened upon removal of the catheterfrom the catheter package. As indicated, a liquid substance comprised inthe package, e.g. a liquid swelling medium for treatment of ahydrophilic catheter, is allowed to drain out of the package through theholes 77 provided in the proximal end of the catheter. The proximal endof the catheter and package is, for simplification of the drawing, leftof the FIGS. 7A and 7B. In FIG. 7C, the proximal end of the package isleft out. However, the proximal end of the package may be closed e.g. bya closure of any kind.

FIG. 8A shows an embodiment of the invention, wherein the distal end ofthe package is closed by a detachable closure 80. The closure isprovided with an outlet 81 for draining liquid substances out of thepackage. In a first position of the catheter in relation to the packageand the closure, see FIG. 8A, the outlet is closed by the distal end ofthe catheter. When the catheter is removed from the package, the outletis opened, whereby liquid substances is drained out of the package.

FIGS. 9-11 shows different embodiments of the invention wherein the hosemember is connected to a reservoir for collection of liquid substances,e.g. for collection of urine and/or a saline solution having been usedfor establishing a low friction surface character of the catheter priorto use.

Referring to FIG. 9, the valve 90 may preferably be provided as aone-way closure, so as to ensure that liquids drained into the reservoirdoes not flow back through the hose member and/or through the catheter.The reservoir is provided with a draining spout or valve 91 for drainingthe liquid substances out of the reservoir. As an example, the drainingvalve may be opened by tearing off a top part of the valve. For thispurpose the reservoir may preferably be provided with a weakening line92. The reservoir may preferably be formed as a bag with a substantiallyflat bottom part 93.

Thereby it will be possible for the user to leave the reservoir on aflat surface, e.g. on the floor, while catheter is inserted into theurethra and while urine is drained into the reservoir. Instructionsrelating to the opening of the draining valve may preferably be printedon the reservoir. The handles 94, 95 gives the user a better grip, e.g.when emptying the reservoir. For this purpose, it will be specificallyappropriate to use both handles in combination, so that the reservoir islifted in the top handles 95, while the rear handle 94 is used to rotatethe reservoir. In this respect it should be kept in mind that the userwould typically be at least partly motorically disabled. The assemblyfurther comprises a closure 96 for opening and closing the assembly,respectively. FIG. 9 shows an embodiment of the combined assembly andreservoir, wherein a compartment 97, in the joint 98 is telescopicallyjoined to the hose 99.

FIG. 10 shows an embodiment of the assembly of FIG. 9, wherein acompartment 100 is attached to the hose member 101 by means of acoupling 102.

FIG. 11 shows an embodiment of the assembly of FIG. 10, wherein thecompartment 100 is attached to the hose member 101 by means of aweakened tear-line 103.

It should be understood that the shown embodiments of the assemblywherein the catheter assembly and a reservoir. However, the reservoirmay be used independently from the catheter assembly. As an example, asimilar reservoir as shown in FIGS. 10-13 may be used in connection withindwelling catheters or in connection with any other kind of catheters,e.g. as a leg-bag, attached to the leg via. leg-straps.

The invention being thus described, it will be apparent that the samemay be varied in many ways. Such variations are not to be regarded as adeparture from the spirit and scope of the invention, and all suchmodifications as would be recognized by one skilled in the art areintended to be included within the scope of the following claims.

What is claimed is:
 1. A catheter assembly configured to allownon-contaminated insertion of a catheter into a urinary canal, thecatheter assembly comprising: a urinary catheter defining a conduitextending between a proximal end and an opposite distal end of theurinary catheter; a catheter package defining a cavity with the urinarycatheter retained in the cavity of the catheter package, the catheterpackage having a removable portion that is removable to define acatheter outlet, where the urinary catheter is movable through thecatheter outlet of the catheter package; and a sealing structureconnected to the urinary catheter and adapted to slide relative to thecatheter package to provide a substantially liquid tight seal betweenthe catheter package and the urinary catheter when the urinary catheteris moved through the catheter outlet of the catheter package.
 2. Thecatheter assembly of claim 1, further comprising: a cap that isremovable from the catheter outlet and attachable to the catheter outletto provide a closed catheter outlet.
 3. The catheter assembly of claim1, wherein the proximal end of the urinary catheter is movable throughthe catheter outlet of the catheter package.
 4. The catheter assembly ofclaim 1, wherein the catheter package is a tubular catheter package. 5.The catheter assembly of claim 1, wherein the catheter outlet is formedin a proximal end of the catheter package.
 6. The catheter assembly ofclaim 1, wherein the sealing structure includes a ring shaped memberarranged between an inner surface of the catheter package and an outersurface of the urinary catheter.
 7. The catheter assembly of claim 6,wherein the ring shaped member is adapted to co-operate with an inwardlyextending protrusion of the inner surface of the catheter package. 8.The catheter assembly of claim 6, wherein the ring shaped member isadapted to co-operate with an outwardly extending protrusion of theurinary catheter.
 9. A urinary catheter of claim 1, wherein the catheterpackage is provided with an opening for draining liquid out of thecatheter package, the opening is closeable by a closing structureconnected to the urinary catheter.
 10. The catheter assembly of claim 9,wherein the closing structure includes a flow channel co-operating withthe opening in the catheter package.
 11. The catheter assembly of claim9, wherein, with the closing structure positioned in the opening, theliquid is prevented from flowing out from the conduit of the urinarycatheter and out of the catheter package.
 12. The catheter assembly ofclaim 9, wherein, with the closing structure removed from the opening,the liquid is allowed to flow from the conduit of the urinary catheterand out of the catheter package.
 13. The catheter assembly of claim 1,wherein the catheter package is provided with a variable length,allowing the catheter package to be compacted to expose the proximal endof the urinary catheter out through the catheter outlet.
 14. Thecatheter assembly of claim 13, wherein the variable length of thecatheter package is provided with a telescopic arrangement between afirst part of the catheter package in relation to a second part of thecatheter package.
 15. The catheter assembly of claim 13, wherein thevariable length of the catheter package is provided a concertina foldedwall part of the catheter package.